The company is testing Hylenex, a liquid injectable formulation that includes the active pharmaceutical ingredient recombinant human hyaluronidase (rHuPH20). Hylenex was approved by the FDA for use as a spreading agent to increase the absorption and dispersion of other injected drugs late last year.
Subcutaneous hydration is the introduction of fluids under the skin to replace inadequate intake or excessive loss of water and electrolytes during illness or operation.
The study is designed to determine the subcutaneous infusion flow rate of lactated Ringer’s solution with and without Hylenex, assess the subcutaneous infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability.
Lactated Ringer’s solution is a widely used fluid for intravenous rehydration. At is composed of boiled distilled water containing sodium chloride, potassium chloride, and calcium chloride in the same concentrations as found in bodily fluids.
The double-blind, placebo-controlled study has reached its target enrollment of 50 evaluable subjects. Results are expected to be presented in February this year.